FDA Adverse Event
Malfunction
Summary report: N
CONSULTA
MDR report key: 1864775
·
Received October 12, 2010
Report
- Report Number
- 6000144-2010-05148
- Event Type
- Malfunction
- Date Received
- October 12, 2010
- Date of Event
- July 26, 2010
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- NIK
- PMA / PMN Number
- P010031/S084
- Removal / Correction Number
- ASKU
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT SINCE THE CHANGE OUT, THE ATRIAL LEAD IMPEDANCE HAS TRIPPED ON 3 OCCASIONS FOR A VALUE GREATER THAN 2000 OHMS. THE BASELINE WAS STEADY APART FROM THESE 3 OUT OF RANGE VALUES. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONSULTA | IMPLANTABLE PACEMAKER/CARDIO/DEFIB | NIK | MEDTRONIC MED REL, INC. | D224TRK | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Other | D224TRK IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 2187 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD |